Understanding the Effect of Metformin on Corus CAD (MET Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioDx
- 入组人数
- 37
- 主要终点
- Metformin effect on Corus CAD
研究概览
简要总结
The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.
详细描述
The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Any of the following:
- •Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
- •Low-risk unstable angina, or
- •Asymptomatic individuals with a high probability of CAD
- •Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:
- •HgA1C: >5.7% - <6.4%,
- •BMI> 35 kg/m2
- •Age< 60 yrs
- •Prior Gestational Diabetes Mellitus
- •FPG: >100mg/dl - <126mg/dl
- •OGTT: >140mg/dl - <200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent
排除标准
- •History of or current level of HbA1C >6.5
- •History of or current prescription of metformin or any other diabetic medication
- •History of myocardial infarction (MI) or prior revascularization
- •Current MI or acute coronary syndrome (ACS)
- •Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
- •Current systemic infectious or systemic inflammatory conditions
- •Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents
结局指标
主要结局
Metformin effect on Corus CAD
时间窗: 7 days (+7days)
Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results
次要结局
未报告次要终点